Delving Into Modular Cleanroom Designs For Drug Manufacturing

By Grant Merrill

The biopharma industry is moving towards advanced therapy medicinal products (ATMP) for treating chronic conditions. These therapies aim to treat the root cause of a disease and offer potential cures without the need for repeated dosages or long-term care. ATMPs are gaining traction, with thousands of clinical trials currently in progress for these treatments. Due to the sensitive nature of biologics, they rely on parenteral delivery. Because biologic treatments bypass the body’s natural defense systems when injected, the manufacturing regulations are much more stringent, requiring strict sterile processing to restrict contamination and ensure patient safety.

Here, Grant Merrill, Chief Commercial Officer at AES Clean Technology, explores the increasing demand for cleanroom technology and the advantages modular cleanroom design brings to sterile processing of complex therapies.